OSSEOTITE® OSS410Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® IMPLANT 4 X 10MM · Class 2 · Implant
All models of OSSEOTITE (73)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This OSSEOTITE implant is a dental implant. Reports mostly describe implant fractures and removals linked to inflammation, pain, or peri-implantitis. There are 40 adverse event reports naming this identifier, with 39 injuries, 1 malfunction, and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00844868013174), received between Jul 2, 2020 and Jul 31, 2026 — classified as 40 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (20 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture20
- Adverse Event Without Identified Device or Use Problem19
- Detachment of Device or Device Component1
- Separation Failure1
Patient problems
- Osteolysis15
- No Clinical Signs, Symptoms or Conditions12
- Pain10
- Unspecified Infection10
- Inflammation6
- No Information5
- No Code Available1
- Perforation1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2026Separation Failure
It was reported the mount won't come off. The mount was too tight to remove. Tooth site # 28. Implant was removed. Procedure not completed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50096375 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 34 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24637809 ↗InjuryMar 2, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24486206 ↗InjuryFeb 3, 2026Fracture
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE 36 FRACTURED IN HALF AND THE APICAL PART WAS LEFT INTEGRATED IN ITS POSITION. DR. STATES THERE IS NO APPARENT CAUSE FOR THE FRACTURE.PATIENT EXPERIENCED PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain
MAUDE report 24247693 ↗InjuryJun 6, 2025Fracture; Fracture
DOCTOR REPORTED IMPLANT FRACTURE AT TOOTH SITE 36. IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22157118 ↗InjuryJun 6, 2025Fracture; Fracture
DOCTOR REPORTED IMPLANT FRACTURE AT TOOTH SITE 36.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22157106 ↗InjuryJun 6, 2025Fracture; Fracture
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 46 WAS REMOVED DUE TO FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22157010 ↗InjuryNov 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20646012 ↗InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT THE IMPLANT AT TOOTH #36 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 20460258 ↗InjuryJul 15, 2024Fracture; Fracture
DOCTOR REPORTED THAT IMPLANT WAS IN MOUTH FOR 3 YEARS, PATIENT REFERRED INTENSE PAIN AND HALF OF THE IMPLANT WAS REMOVED, THE OTHER HALF WAS INTEGRATED IN THE BONE. DOCTOR TRIED TO REMOVE THE INTEGRATED PART OF IMPLANT IN ANOTHER EXTRACTION SURGERY. A NEW IMPLANT WITH NEW CROWN WAS PLACED. TOOTH LOCATION 36.
Patient problems: Pain
MAUDE report 19738631 ↗InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER 22 & 24 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19687733 ↗InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED BONE LOSS AT TOOTH SITES 31, 34, 27. IMPLANTS WERE REMOVED.
Patient problems: Osteolysis
MAUDE report 18998102 ↗InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #21 34 & 36 FAILED DUE TO BONE LOSS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. PATIENT WITH BONE TYPE: III.
Patient problems: Osteolysis
MAUDE report 18983756 ↗InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #21 34 & 36 FAILED DUE TO BONE LOSS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. PATIENT WITH BONE TYPE: III
Patient problems: Osteolysis
MAUDE report 18983674 ↗InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 36 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH INFLAMMATION. PATIENT REFERRED PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 18484907 ↗InjuryJan 4, 2024Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 46 FRACTURED AND WAS REMOVED. PATIENT WILL HAVE TO RETURN TO PLACE A NEW IMPLANT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18443279 ↗InjuryDec 13, 2023Fracture; Fracture
DOCTOR REPORTED IMPLANT FRACTURE AT TOOTH SITE 26. DOCTOR ALSO REPORTED INFLAMMATION AND PAIN. A NEW IMPLANT AND SUPERSTRUCTURE WILL BE PLACED.
Patient problems: Inflammation; Pain
MAUDE report 18316940 ↗InjuryOct 24, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation
MAUDE report 17993976 ↗InjuryMay 23, 2023Fracture; Fracture
IT WAS REPORTED THAT 5 YEARS AFTER IMPLANT PLACEMENT, DOCTOR REMOVED IT DUE TO BODY FRACTURE. NO OTHER IMPLANT HAS BEEN PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16989942 ↗InjuryMar 23, 2023Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 FRACTURED DUE TO EXCESSIVE LOAD. THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16599386 ↗InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT CAME TO CLINIC WITH DISCOMFORT IN IMPLANT AREA. IN THE X-RAYS, BONE LOSS IS OBSERVED IN THE SWOLLEN AREA. BONE GRAFT WAS PERFORMED
Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection
MAUDE report 15560057 ↗InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 14684699 ↗InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO BONE LOSS. PATIENT IS A BRUXIST.
Patient problems: Osteolysis
MAUDE report 14684621 ↗InjuryMay 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR CONFIRMED THAT THE DENTAL SURGICAL PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT AND THAT THE PATIENT DID NOT SUFFER ANY TYPE OF NEGATIVE IMPACT ON HIS HEALTH AS A RESULT OF THE EVENT. INFLAMMATION REPORTED AS A CONSEQUENCE OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 14424751 ↗InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE IMPLANT LOCATED IN DENTAL POSITION NUMBER #33 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR CONFIRMS THAT THE DENTAL SURGICAL PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT AND THAT THE PATIENT SHOULD RETURN IN THE FUTURE.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 13505181 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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